Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS

K-Number: K871478 · 1987-05-07

ApplicantProcedure Pak, Inc.
Decision Date1987-05-07
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Pak, Inc.. It received FDA 510(k) clearance on 1987-05-07 under 510(k) number K871478. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS?

SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS is a medical device that received FDA 510(k) clearance on 1987-05-07. The listed applicant is Procedure Pak, Inc.. The 510(k) number is K871478.

When did SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS receive FDA 510(k) clearance?

SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS received FDA 510(k) clearance on 1987-05-07, under 510(k) number K871478.

Who is the listed applicant for SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS?

The FDA 510(k) record lists Procedure Pak, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS?

The FDA product code for SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS is FSM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Procedure Pak, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K861288NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES

Related Devices (Code: FSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑